NCT01710033

A Study Of CP-690,550 In Stable Kidney Transplant Patients

Phase 1, Placebo-controlled, Randomized, Sequential, Parallel-group, Dose Escalation Study to Evaluate 28-day Multiple Dose Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CP-690,550 in Stable Renal Allograft Recipients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort in Stage 2.

Conditions

• Kidney Transplant

Interventions

Type	Name	Description
DRUG	Placebo	Placebo tables twice daily (BID) for 28 days
DRUG	CP-690,550 5 mg BID	CP-690,550 5 mg BID for 28 days
DRUG	CP-690,550 15 mg BID	CP-690,550 15 mg BID for 28 days
DRUG	CP-690,550 30 mg BID	CP-690,550 30 mg BID for 28 days

Timeline

• Start date: 2003-09-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2012-10-18
• Last updated: 2012-12-26
• Results posted: 2012-12-26

Locations

11 sites across 1 country: United States